Pharmaceutical giant Pfizer is developing a new type of anti-coronavirus vaccine in cooperation with the German BioNTech company. The companies previously set a goal of submitting the vaccine to the emergency use approval unit (EUA) of the US Food and Drug Administration (FDA) for mid-October. Pfizer President and CEO Albert Bourla outlined the steps that should be taken in a public letter published last Friday. And it changed the date when the vaccine will be submitted for examination by the official institution in order to “eliminate a great confusion”.
Bourla noted that the vaccine must go through three stages before FDA approval can begin. The first step is to make sure it is effective in preventing COVID-19 infection in most patients. Pfizer believes data should arrive by the end of October. This process includes the review of blinded data by an independent committee of scientists. The committee’s conclusions will be shared with the public shortly after they are sent to Pfizer.
Pfizer then has to prove that the vaccine is safe and that the manufacturing process can guarantee the consistency and quality of the vaccine. The company said it expects to have appropriate data for the production process in the coming weeks and that it expects security trials to be completed by the third week of November.
Bourla’s repeated emphasis on providing “more clarity” and reducing confusion seems to be related to the political noise from the US administration, in other words, from the White House in recent months. Trump has repeatedly assured that a vaccine will be ready before the November 3 elections. This has raised concerns that the White House might try to launch an unsafe vaccine to earn points with voters. At risk of losing the public’s confidence in the effectiveness of Covid-19 vaccines, the FDA has issued stricter rules requiring more safety data for emergency approval reviews. The White House blocked these instructions, then quickly unblocked them. Bourla, “We work at the speed of science.” said.
Right now, Pfizer’s eyes seem to be turned to approval in the US. However, BioNTech plans to receive emergency approvals in Europe shortly after the FDA review, according to the Wall Street Journal. The companies plan to produce 100 million doses by the end of the year. This would be sufficient for two doses of vaccine required for 50 million people.